ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE

K990427 · Alliance Rubber Products Sdn. Bhd. · LZA · Apr 23, 1999 · General Hospital

Device Facts

• Record ID: K990427
• Device Name: ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
• Applicant: Alliance Rubber Products Sdn. Bhd.
• Product Code: LZA · General Hospital
• Decision Date: Apr 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6250
• Device Class: Class 1

Intended Use

A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Device Story

Nitrile examination gloves; non-sterile; powder-free. Worn on hands of healthcare personnel. Acts as a physical barrier to prevent cross-contamination between patient and clinician. Used in clinical settings. Protects both patient and provider from potential contaminants.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Nitrile rubber material; non-sterile; powder-free; examination glove form factor.

Indications for Use

Indicated for use by healthcare and similar personnel to prevent cross-contamination between the wearer and the patient.

Regulatory Classification

Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 3 1999

Mr. Chua Hooi Koon Alliance Rubber Products Sdn. Bhd. Lot 2716 & 2720, MK 7, Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Pulau Pinang, MALAYSIA

K990427 Re : Arsoft Nitrile Examination Gloves, Trade Name: Non-Sterile Powder-Free Regulatory Class: I Product Code: LZA Dated: August 2, 1998 February 11, 1999 Received:

Dear Mr. Koon

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Koon

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaracron cherclesa, "Mozianally by Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/1 description: The image shows the logo for Alliance Rubber Products Sdn.Bhd. The logo consists of a stylized, intertwined symbol on the left, followed by the company name in a clear, bold font. The text is aligned horizontally, with the symbol positioned to the left of the company name. The overall design is simple and professional.

Lot 2716 & 2720, MK 7, Kawasan Perindustrian Bukit Panchor, 14300 Nibong Tebal, Company No. : 52446-U Pulau Pinang, Malaysia. Fax : [phone] Tel : [phone] E-mail : [e-mail] Our Ref : CHK/080299/04 Date : 08-02-99 Page :1/1 Your Ref :

## ATTACHMENT 2 :

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## INDICATION FOR USE

Applicant : ALLIANCE RUBBER PRODUCTS SDN. BHD.

510(k) Number (if known) :

Device Name : NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE.

Trade Name : ARsoft OR other client's trade name.

Indication For Use :

A medical gloves is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Concurrence of CDRH Office of Device Evaluation (ODE)

*S. Lin*
(Division Sign-Off)
Division of Dental, Infection,
and General Hospital Devices
510(k) Number K990427

Prescription Use **__** OR Over-The-Counter X
Per 21 CFR 801.109